Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
Status unconfirmed · Not applicable
Conditions studied: Prolapse of Vaginal Vault After Hysterectomy
In brief
Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy? The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications. The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.
Key facts
- Study ID
- NCT01364025
- Run by
- Kaiser Permanente
- People needed
- 800
- Starts
- 2011-08-01
- Expected to finish
- 2021-02-21
- Last updated by the study team
- 2020-02-25
Who can join
Age: 21 and older, up to 99. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
- Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
- Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
- No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
You may not qualify if…
- Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
- Anticipated geographic relocation within the 12 months after surgery
- Inability to provide informed consent or to complete testing or data collection.
Where it is running
- Kaiser Permanente San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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